NCT04765254

Brief Summary

It was observed during the last period of COVID-19 pandemic that diabetic patients had a worse prognosis and more deteriorated clinical features than other patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

February 20, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

28 days

First QC Date

February 18, 2021

Last Update Submit

February 19, 2021

Conditions

Keywords

COVID-19prognosismortality rateDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Investigation of bad prognosis cause for covid-19 diabetic patients

    number of diabetic patients with deteriorated case and to find the best hypoglycemic drug used for diabetic patients with covid-19 infection

    30 days

Study Arms (2)

control group

COVID-19 infected patients with no other comorbidities and they take the routine protocol from the Egyptian ministry of health

Other: no intervention as it is an observational study

diabetic group

COVID-19 infected patients with diabetes comorbidity and they receive the routine protocol for covid treatment in addition to their hypoglycemic drugs

Other: no intervention as it is an observational study

Interventions

both groups will be monitored for the disease progress or deterioration and mortality rate

control groupdiabetic group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients infected with COVID-19 either diabetic or have no comorbidities, inpatients

You may qualify if:

  • Patients infected with COVID-19 male or female 30 years old or more inpatients

You may not qualify if:

  • have othe comorbidities other than type 2 diabetes mellitus pregnant women below 30 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University teaching hospitals

Cairo, Kasr Al Ainy, 11311, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samoles for routine CBC, D dimer and INR tests

MeSH Terms

Conditions

COVID-19Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Dalia Zaafar, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of pharmacology

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 21, 2021

Study Start

February 20, 2021

Primary Completion

March 20, 2021

Study Completion

April 10, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations